Using Mobile Technology to Enhance Early Psychosis Treatment Delivery

NCT03303456 | Completed

• 1 other identifier: 563584
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

This project tests the feasibility of implementing a smartphone application - Ginger.io - in the UC Davis Early Psychosis Program, and investigates whether mobile health technology can improve treatment delivery and outcomes in individuals with early psychosis. Ginger.io is a smartphone application that utilizes methods of passive data collection (i.e. data gathered without active interaction/contribution from the user) to gather communication, movement, and interaction data from smartphone devices to model individuals' social, physical, and mental health. These models are used to infer health-related outcomes and could inform treatment. By implementing the Ginger.io application in the UC Davis Early Psychosis Program with an integrated clinical and research infrastructure, the investigators will be able to quickly determine its feasibility for use in early psychosis populations, while simultaneously developing its ability to systematically capture aspects of relapse and recovery that are unique to this patient population. Objectives: This project has three principle objectives related to early psychosis care: 1) improve treatment delivery, 2) improve patient outcomes, and 3) lower treatment costs. The project will target individuals in the early stages of psychotic illness, including individuals at high risk for developing a psychotic illness (termed "clinical high risk" or CHR) and individuals within three years of their first psychotic episode (termed "first episode psychosis" or FEP). The early stages of psychotic illness represent a critical period for intervention; early identification of clinical deterioration and subsequent targeted intervention is crucial for rapid remission of symptoms and reduced relapse rates. However, without the information necessary to identify patients in need of such intervention, providers are limited in their ability to respond rapidly. Within the UCD Early Psychosis Program, a mobile health application such as Ginger.io has the potential to equip the providers and caregivers with valuable insight into a patient's status in real-time without the burden of increased appointments and intrusive monitoring, allowing the identification of early psychosis patients most in need of outreach, and routing of treatment resources to the right patients at the right time.

Conditions

Psychosis; Clinical High Risk for Psychosis

Keywords

early psychosis; clinical high risk; mobile health

Outcome Measures

Primary Outcomes (8)

• Feasibility of using the Ginger.io app

  measured by number of enrolled and active participants versus total patient population invited

  end of study, maximum of 18 months

• Acceptability of the Ginger.io app

  Measured with satisfaction survey ratings of Ginger.io by patients and clinicians.

  6 months

• Brief Psychiatric Rating Scale (BPRS)

  Brief Psychiatric Rating Scale (BPRS) is a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.

  through study completion, maximum of 18 months

• Global Functioning Scale:Social

  Global Functioning Scale: Social provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale.

  through study completion, maximum of 18 months

• Critical Incidents

  Count of clinic contacts, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.

  through study completion, maximum of 18 months

• CGI

  The CGI (Haro et al., 2003) is a brief 12-item scale assessing illness severity and degree of improvement over follow-up that is appropriate for use in clinical or research settings.

  through study completion, maximum of 18 months

• Global Assessment of Functioning

  The GAF is a numeric scale (0 through 100) that provides a rating of an individual's social, occupation, and psychological functioning.

  through study completion, maximum of 18 months

• Global Functioning Scale: Role

  Global Functioning Scale: Role provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale.

  through study completion, maximum of 18 months

Secondary Outcomes (5)

• Medication Adherence (MARS)

  through study completion, maximum of 18 months

• Therapeutic Alliance

  through study completion, maximum of 18 months

• Insight

  through study completion, maximum of 18 months

• Clinically relevant patient alerts

  through study completion, maximum of 18 months

• Cost of Care

  through study completion, maximum of 18 months

Study Arms (3)

Clinical high risk (CHR)

EXPERIMENTAL

Subjects at clinical high risk (CHR) for psychosis and/or bipolar disorder, aged 13-30 years. CHR participants will have no history of psychosis and will demonstrate attenuated psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a substantial drop in functioning over the past year. Assigned Mobile health application - Ginger.io

Other: Mobile health application - Ginger.io

First Episode Psychosis (FEP)

EXPERIMENTAL

First Episode Psychosis (FEP) subjects aged 13-30 meeting criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or another psychotic, non-schizophrenia diagnosis including those with bipolar disorder. FEP participants will be ascertained three years or less from illness onset and have diagnoses of affective (i.e. bipolar) and non-affective psychosis (i.e. schizophrenia) according to DSM-IV criteria. Assigned Mobile health application - Ginger.io

Other: Mobile health application - Ginger.io

Healthy Controls (HC)

EXPERIMENTAL

Healthy individuals with no current/past axis I disorders according to DSM-IV criteria and no first-degree relative with a psychotic disorder. Assigned Mobile health application - Ginger.io

Other: Mobile health application - Ginger.io

Interventions

Mobile health application - Ginger.io OTHER

the Ginger.io is a smartphone application allowing for daily surveys assessing mood and social interactions, and weekly surveys assessing symptoms and psychosocial functioning. Collects passive movement and interaction data

Clinical high risk (CHR); First Episode Psychosis (FEP); Healthy Controls (HC)

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 13-30, English fluency

You may not qualify if:

• IQ Below 70, history of neurological disorders, or current substance abuse/dependence.

Sponsors & Collaborators

• University of California, Davis: lead
• Ginger.io: collaborator

Study Sites (1)

UC Davis Imaging Research Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Tara A Niendam, Ph.D.

  UC Davis Dept of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: October 6, 2017
• Study Start: December 14, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)